This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).
This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MAFLD patients with obesity and T2DM. Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).
Percentage change in body weight relative to baseline
Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.
Time frame: Baseline to 12 weeks
Changes in energy expenditure
The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).
Time frame: Baseline to 12 weeks
Change in patient's weight relative to the baseline
Evaluation of the change in patient's weight relative to the baseline after 12 weeks with CS0159
Time frame: Baseline to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Evaluate the safety and tolerability of CS0159 combined with semaglutide during a 12-week treatment period
Time frame: Baseline to 12 weeks
Change in patient's glucose oxidation
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
Time frame: Baseline to 12 weeks
Change in patient's lipid oxidation
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
Time frame: Baseline to 12 weeks
Percentage change in HbA1c relative to baseline
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Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 12 weeks of treatment.
Time frame: Baseline to 12 weeks
Changes relative to baseline in BMI
Changes in body mass index (BMI) relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks
Changes relative to baseline in body composition
Changes in body composition analysis relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks
Changes relative to baseline in waist circumference
Changes in waist circumference relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks
Changes relative to baseline in waist to hip ratio (WHR)
Changes in waist to hip ratio (WHR) relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum liver function parameters
including alanine aminotransferase, aspartate aminotransferase, glutamyltransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, total protein, albumin, and total bile acid.
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum lipid profile
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
Time frame: Baseline to 12 weeks
Changes relative to baseline in plasma glucose levels
including fasting plasma glucose and 2-hour post-prandial plasma glucose
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum insulin levels
including fasting serum insulin and 2-hour post-prandial serum insulin
Time frame: Baseline to 12 weeks
Changes in peripheral blood metabolomics and proteomics relative to baseline
Changes in peripheral blood metabolomics and proteomics relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline after 12 weeks of administration
Time frame: Baseline to 12 weeks